Study to Evaluate the Safety and Efficacy of SDP-4 in Subjects With Dry Eye Disease (DED)
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Ocular, Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/30/2019 |
| Start Date: | April 2019 |
| End Date: | January 31, 2020 |
| Contact: | Jamie Christensen |
| Email: | jamiechristensen@silk-tech.com |
| Phone: | 763-463-9595 |
A Phase 2, Multicenter, Double-Masked, Randomized, Vehicle-Controlled, Parallel Group, Dose-Response Study of SDP-4 Ophthalmic Solution in Subjects With Dry Eye Disease (DED)
SDP-4-CS201, is a Phase 2, multi-center, double-masked, randomized, vehicle-controlled,
dose-response, parallel-group study designed to evaluate the ocular and systemic safety and
efficacy of SDP-4 ophthalmic solution in subjects with moderate to severe dry eye disease
over a 12-week treatment period. Three concentrations (0.1%, 1.0% and 3.0%) of SDP-4
ophthalmic solution will be given to parallel groups via topical ocular instillation BID.
dose-response, parallel-group study designed to evaluate the ocular and systemic safety and
efficacy of SDP-4 ophthalmic solution in subjects with moderate to severe dry eye disease
over a 12-week treatment period. Three concentrations (0.1%, 1.0% and 3.0%) of SDP-4
ophthalmic solution will be given to parallel groups via topical ocular instillation BID.
Inclusion Criteria:
- Have DED in both eyes for ≥ 6 months prior to Visit 1/Screening.
- Total score ≥ 40 on the SANDE questionnaire.
- Tear break-up time (TBUT) of ≤ 6 seconds in both eyes.
- Anesthetized Schirmer's test tear volume ≥ 4 mm and <10 mm in both eyes.
Exclusion Criteria:
- Ocular surface corneal disease, other than DED.
- Lid margin disorder other than meibomian gland dysfunction (MGD).
- Any previous reconstructive or cosmetic eyelid surgery that may affect the normal
function of the lids
- Any previous invasive glaucoma and/or corneal surgery
- Corneal refractive surgery in the 12 months prior to Visit 1/Screening.
- Cataract extraction within 90 days prior to Visit 1/Screening.
- Use of ophthlamic corticosteroids, NSAIDs, antibiotics, antihistamines, IOP lowering
medication, in the 30 days prior to Visit 1/Screening
- Serious systemic disease or uncontrolled medical condition that in the judgment of the
Investigator could confound study assessments
We found this trial at
23
sites
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12665 Garden Grove Boulevard
Garden Grove, California 92843
Garden Grove, California 92843
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